72 FR 143 pgs. 41077-41079 - Proposed Data Collections Submitted for Public Comment and Recommendations
Type: NOTICEVolume: 72Number: 143Pages: 41077 - 41079
Docket number: [60Day-07-0666]
FR document: [FR Doc. E7-14432 Filed 7-25-07; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Centers for Disease Control and Prevention
Official PDF Version: PDF Version
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-07-0666]
Proposed Data Collections Submitted for Public Comment and Recommendations
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention (CDC) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call 404-639-5960 and send comments to Maryam I. Daneshvar, CDC Acting Reports Clearance Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail to omb@cdc.gov.
Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Written comments should be received within 60 days of this notice.
Proposed Project
National Healthcare Safety Network (NHSN) (OMB Control No. 0920-0666)-Revision-National Center for Preparedness, Detection, and Control of Infectious Diseases (NCPDCID), Centers for Disease Control and Prevention (CDC).
Background and Brief Description
The National Healthcare Safety Network (NHSN) is a system designed to accumulate, exchange, and integrate relevant information and resources among private and public stakeholders to support local and national efforts to protect patients and to promote healthcare safety. Specifically, the data is used to determine the magnitude of various healthcare-associated adverse events and trends in the rates of these events among patients and healthcare workers with similar risks. The data will be used to detect changes in the epidemiology of adverse events resulting from new and current medical therapies and changing risks.
Healthcare institutions that participate in NHSN voluntarily report their data to CDC using a web browser-based technology for data entry and data management. Data are collected by trained surveillance personnel using written standardized protocols. This application to OMB includes a significant increase in the number of burden hours to the previously approved data collection. The increase is due to inclusion of new forms and an increased number of respondents.
NHSN was first approved by OMB in 2005 and CDC proposes to revise this data collection by adding new modules to the NHSN as well as modifying currently approved forms. Four new forms are proposed: (1) Healthcare Worker Influenza Vaccination form; (2) Healthcare Worker Influenza Antiviral Medication Administration form; (3) Pre-season survey on Influenza Vaccination Programs for Healthcare Workers; and (4) Post-season Survey on Influenza Vaccination Programs for Healthcare Workers. The purpose of these new forms is to help participating healthcare institutions and CDC to: (1) Monitor influenza vaccination coverage among healthcare personnel at individual facilities and to provide aggregate coverage estimates for all participating facilities; (2) monitor progress towards attaining the Healthy People 2010 goal of 60% vaccination coverage among healthcare personnel; (3) monitor influenza vaccination coverage by ward/unit of the facility or occupational group so that areas or groups with low vaccination rates can be targeted for interventions; (4) monitor adverse reactions related to receipt of the vaccine or receipt of antiviral medications; and (5) assess the characteristics of influenza vaccination programs pre- and post-influenza season to identify practices associated with high immunization rates. The total estimated annual burden for these forms is 13,800 hours.
CDC is proposing to add an additional form, Central Line Insertion Practices Monitoring Form, to the Patient Safety Component Device Associated Module. This new form will enable participating facilities and CDC to (1) monitor central line insertion practices in individual patient care units and facilities and provide aggregate data for all participating facilities (facilities have the option of recording inserter-specific adherence data); (2) link gaps in recommended practice with the clinical outcome both in individual facilities and for all participating facilities; (3) facilitate quality improvement by identifying specific gaps in adherence to recommended prevention practices, thereby helping to target intervention strategies for reducing central line infection rates. The total estimated annual burden for this form is 12,500 hours.
CDC proposes to add the Multi-Drug Resistant Organism (MDRO) Prevention Process Monitoring Module to the Patient Safety Component. This module consists of four forms: (1) MDRO Prevention Process Monitoring Form; (2) MDRO Infection Event Form; (3) Laboratory-identified MDRO Event Form; and (4) Laboratory-identified MDRO Event Summary Form. The purpose of these forms is to: (1) Monitor processes and practices in individual patient care units and facilities and to provide aggregate adherence data for all participating facilities; (2) link gaps in recommended practice with the clinical outcome (i.e., MDRO infection) both in individual facilities and for all participating facilities; (3) facilitate quality improvement by identifying specific gaps in adherence to recommended prevention practices, thereby helping to target intervention strategies for reducing MDRO infection rates. The total estimated annual burden for these forms is 244,500 hours.
The fourth new proposed collection to the NHSN is the High Risk Inpatient Influenza Vaccination Module. This module consists of four forms: (1) Influenza High Risk Inpatient Influenza Vaccine Summary Form-Method A; (2) Influenza High Risk Inpatient Influenza Vaccine Summary Form-Numerator Data Form Method B; (3) Influenza High Risk Inpatient Influenza Vaccine Summary Form-Method B; and (4) Influenza High Risk Inpatient Influenza Vaccine-Denominator Form Method B. The purpose of these forms is to: (1) Monitor influenza vaccination practices for high risk patients and provide aggregate data in regard to the number of high risk patients receiving vaccination, those already vaccinated, and those who decline due to medical contraindications or other reasons; and (2) to identify reasons that high risk patients are not receiving influenza vaccination. The total estimated annual burden of these forms is 161,250 hours.
CDC is also proposing to open enrollment to any healthcare facility; therefore this submission includes a registration form (Registration Form) to collect necessary registration information. The total estimated annual burden for this form is 125 hours.
A Long Term Acute Care Hospital (LTACH) survey form is included in this submission. This survey will allow long term acute care hospitals and CDC to collect information on LTACH characteristics, infection control practices, and microbiology laboratory practices. This data will provide CDC with more comprehensive information on all of the types of facilities that utilize the NHSN. The total estimated annual burden for this form is 38 hours.
Finally, CDC also proposes to make minor edits and modifications to currently approved forms.
CDC is also adding an increased number of participating healthcare institutions from a wide spectrum of settings. Part of this increase in burden hours is due to the passage of legislation in many states requiring mandatory reporting of healthcare-associated infections. Some states plan to use or are using NHSN as their data collection system to meet this mandate.
Participating institutions must have a computer capable of supporting an Internet service provider (ISP) and access to an ISP. The only other cost to respondents is their time to complete the appropriate forms.
| Form | Number of respondents | Average number of responses per respondent | Average burden per response (in hours) | Total burden hours |
|---|---|---|---|---|
| Facility Contact Information | 1,500 | 1 | 10/60 | 250 |
| Patient Safety Component Hospital Survey | 1,500 | 1 | 30/60 | 750 |
| Agreement to Participate and Consent | 1,500 | 1 | 15/60 | 375 |
| Group Contact Information | 1,500 | 1 | 5/60 | 125 |
| Patient Safety Monthly Reporting Plan | 1,500 | 9 | 35/60 | 7,875 |
| Healthcare Personnel Safety Reporting Plan | 150 | 9 | 10/60 | 225 |
| Primary Bloodstream Infection (BSI) | 1,500 | 36 | 30/60 | 27,000 |
| Pneumonia (PNEU)-also includes Any Patient Pneumonia Flow Diagram and Infant and Children Pneumonia Flow Diagram | 1,500 | 72 | 30/60 | 54,000 |
| Urinary Tract Infection (UTI) | 1,500 | 27 | 30/60 | 20,250 |
| Surgical Site Infection (SSI) | 1,500 | 27 | 30/60 | 20,250 |
| Dialysis (DI) | 80 | 90 | 15/60 | 1,800 |
| Antimicrobial Use and Resistance (AUR)-Microbiology Laboratory Data | 1,500 | 45 | 3 | 202,500 |
| Antimicrobial Use and Resistance-Pharmacy Data | 1,500 | 36 | 2 | 108,000 |
| Denominators for Intensive Care Unit (ICU)/Other locations (Not NICU or SCA) | 1,500 | 18 | 5 | 135,000 |
| Denominators for Specialty Care Area (SCA) | 1,500 | 9 | 5 | 67,500 |
| Denominators for Neonatal Intensive Care Unit (NICU) | 1,500 | 9 | 4 | 54,000 |
| Denominator for Procedure | 1,500 | 540 | 8/60 | 108,000 |
| Denominator for Outpatient Dialysis | 80 | 9 | 5/60 | 60 |
| Patient Safety Component-Outpatient Dialysis Center Practices Survey | 80 | 1 | 1 | 80 |
| List of Blood Isolates | 1,500 | 1 | 1 | 1,500 |
| Manual Categorization of Positive Blood Cultures | 1,500 | 1 | 1 | 1,500 |
| Exposures to Blood/Body Fluids | 150 | 50 | 1 | 7,500 |
| Healthcare Personnel Post-exposure Prophylaxis | 150 | 10 | 15/60 | 375 |
| Healthcare Personnel Demographic Data | 150 | 200 | 20/60 | 10,000 |
| Healthcare Personnel Vaccination History | 150 | 300 | 10/60 | 7,500 |
| Annual Facility Survey | 150 | 1 | 8 | 1,200 |
| Implementation of Engineering Controls | 150 | 1 | 30/60 | 75 |
| Healthcare Worker Survey | 150 | 100 | 10/60 | 2,500 |
| Healthcare Personnel Influenza Vaccination Form | 150 | 500 | 10/60 | 12,500 |
| Healthcare Personnel Influenza Antiviral Medication Administration Form | 150 | 50 | 10/60 | 1,250 |
| Pre-season Survey on Influenza Vaccination Programs for Healthcare Workers | 150 | 1 | 10/60 | 25 |
| Post-Season Survey on Influenza Vaccination Programs for Healthcare Workers | 150 | 1 | 10/60 | 25 |
| Central Line Insertion Practices Adherence Monitoring Form (CLIP) | 1,500 | 100 | 5/60 | 12,500 |
| Laboratory Testing | 150 | 100 | 15/60 | 3,750 |
| MDRO Prevention Process and Outcome Measures Monthly Monitoring Form | 1,500 | 24 | 10/60 | 6,000 |
| MDRO Infection Event Form | 1,500 | 72 | 30/60 | 54,000 |
| Laboratory Identified MDRO Event Form (LIME) | 1,500 | 240 | 30/60 | 180,000 |
| Registration Form | 1,500 | 1 | 5/60 | 125 |
| High Risk Inpatient Influenza Vaccine-Summary Form Method A | 1,500 | 5 | 16 | 120,000 |
| High Risk Inpatient Influenza Vaccine-Numerator Data Form Method B | 500 | 250 | 10/60 | 20,833 |
| High Risk Inpatient Influenza Vaccine-Summary Form Method B | 500 | 5 | 4 | 10,000 |
| High Risk Inpatient Influenza Vaccine-Denominator Data Form Method B | 500 | 250 | 5/60 | 10,417 |
| Laboratory Identified MDRO Event-Summary Form | 1,500 | 3 | 1 | 4,500 |
| Long-term Acute Care Hospital Survey | 75 | 1 | 30/60 | 38 |
| Total | 1,276,153 |
Dated: July 19, 2007.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for Disease Control and Prevention.
[FR Doc. E7-14432 Filed 7-25-07; 8:45 am]
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